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FDA
reviewing safety Data regarding Botox and Myobloc
On February
8, 2008, the U.S. Food and Drug administration notified the public
that Botox and Botox cosmetic and Myobloc have been linked in some
cases to adverse reactions following treatment of a variety of conditions
using a wide range of doses.
These
reactions including respiratory failure and death appear to be related
to the spread of the toxin to areas distant from the site of injection,
and mimic symptoms of botulism, which may include difficulty swallowing,
weakness and breathing problems. The most severe ones included respiratory
failure and death were found in children treated for limb spasticity
associated with cerebral palsy which is an off-label use not approved
by FDA.
Botox
(Botulinum toxin type A) and Myobloc (Botulinum toxin type B) are
neurotoxins produced by the bacterium Clostridium Botulinum. They
are used in minute doses to treat muscle spasms (such as blepharospasm,
cervical dystonia and sever primary axillary hyperhydrosis) and
as a cosmetic treatment for the temporary improvement in the appearance
of moderate to severe facial frown lines.
FDA
is currently reviewing safety data from clinical studies submitted
by the drugs’ manufacturers, as well as post-marketing adverse event
reports and medical literature. After
completion of the review, the FDA will communicate to the public
its conclusions, resulting recommendations, and any regulatory actions.
More
about this subject could be found at: www.fda.gov/bbs/topics/NEWS/
2008/NEW01796.html
FDA:
Use caution with Ayurvedic Products
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FDA:
Use caution with Ayurvedic Products
Ayurvedic
medicine is a traditional system of healing arts originated in India.
It involves using products such as spices, herbs, vitamins, proteins,
minerals and metals (mercury, lead, iron, zinc). These products
are commonly sold on the internet
or in stores in the US.
A study
published on August 27, 2008, issue of the journal of the American Medical
Association (JAMA), demonstrated that one fifth of U.S.-manufactured
and Indian-manufactured Ayurvedic products bought on the Internet
contained detectable levels of lead, mercury and arsenic.
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All metal-containing
products exceeded one or more standards for acceptable daily metal
intake. FDA warned consumers that these products are not reviewed
or approved by the Drug Evaluation and Research (CDER) department.
To read more about this
topic, please visit: www.fda.gov/consumer/updates/
ayurvedic101608.html
Injectable
cosmetic dermal filler
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Injectable
cosmetic dermal fillers
Injectable
cosmetic fillers are nowadays immensely popular. Sizable numbers
of people, even in their 20s, are getting cosmetic procedures using
dermal fillers to soften facial wrinkles or to plump up some parts
of their bodies.
IOMS
believes that people should be better informed of possible risks
involving these procedures, which have been reported to the U.S.
Food and Drug administration.
Also,
health professionals should be updated with recent news involving
this matter.
Recent
reports to the FDA are pointing to the short and long term effects
of these substances ranging from bruising to necrosis. More serious
and unexpected complications have also been reported such as allergic
reactions, facial palsy, disfigurement, and vision problems. Some
of these complications were due to “off-label” use of fillers such
as plumping of lips, cheeks, and under-eye area; others were due
to injections administered by untrained personnel or in settings
other than health clinics or doctor’s offices.
Due
to the unfavorable reports an advisory panel for the FDA
recommended
that labeling of these products should be revised to include the
more serious side effects and how long it would take for these effects
to appear as some reactions show up months after injection.
Also,
a lot of the panel members want manufacturers to do more rigorous
premarket studies.
The
industry and some health professionals were against blaming the
products, but others welcomed most of the recommendations.
Please
visit the following sites to learn more about dermal fillers, side
effects, concerns and FDA advisory panel recommendations:
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www.fda.gov/cdrh/wrinklefillers/
www.usatoday.com/news/health/
2008-11-18-699523247_x.htm
www.medscape.com/viewarticle/
583869
Some
of the reported harmful effects were related to filler injections
under the eye area, such as under-eye mounds, discoloration, and
persistent nodules. Even some reports from around the world talked
about blindness caused by cosmetic injections of silicone oil, fat
and other materials under the eyes. The companies that manufacture
the soft tissue fillers explicitly urge that doctors should not
inject soft tissue fillers into the eyelid area as this procedure
is very risky and requires high knowledge of eyelid anatomy.
Three
cases of renal failure linked to cosmetic soft-tissue filler injections
were reported in the May 2nd, 2008 issue of “Morbidity and Mortality
Weekly Report”. Records indicated that the injections contained
liquid silicone and were administered by unlicensed practitioners
at a facility in North
Carolina. Renal biopsies of 2 cases showed
severe acute tubular necrosis and acute interstitial nephritis,
both cases required renal dialysis and hospitalization for two weeks.
You
can get more details if you go to:
www.eye.taragana.net/archive/soft-tissue-injections-harmful-for-eyes/
www.healthwikinews.com/warning-injections-to-cure-dark-circles-may-be-risky/
www.medscape.com/viewarticle/
573926
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Antihypertensive
agent
Unapproved product containing
prescription medicines recalled
USA.
The US FDA has directed Herbsland Inc.
to recall an unapproved antihypertensive preparation (Ancom
Anti-Hypertensive Compound Tablet) labelled
to contain several prescription medicines. Herbsland
Inc. is recalling all 100 tablet bottles of the preparation that
contains several prescription medicines including reserpine,
diazepam, promethazine and hydrochlorothiazide. The sale of this combination
without a prescription poses serious health risks including sedation,
depression and potentially life threatening blood abnormalities,
although no illnesses have yet been reported. Consumers are urged
to stop taking this preparation and to consult their physician if
they have experienced any adverse event while taking this product.
Reference:
Media Release, 17 Jan 2003.
Available from URL:http://www.fda.gov
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